Label: information for the user

OncoTICE2‑8 x 108UFC

powder forsuspensionintravesical

BCG strain Tice

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.

If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section4.

OncoTICE belongs to the group of medications known as immunostimulants, which act on the body's defense system. Specifically, this medication can stimulate your immune system.

OncoTICE is used for the treatment of superficial bladder cancer. It is also used to prevent the disease from recurring after bladder surgery.

Do not useOncoTICE:

• If you are allergic to the Bacillus Calmette-Guerin (BCG) or to any of the other components of this medication (listed in section6).
• If you have a urinary tract infection. If you have cystitis (inflammation of the bladder), antibiotics will be administered first before starting OncoTICE treatment. It is essential that the antibiotic treatment has ended before starting OncoTICE treatment.
• If you have blood in your urine.
• If you have active tuberculosis.
• If you are being treated with antitubercular medications, such as streptomycin, para-aminosalicylic acid, isoniazid, rifampin, and ethambutol.
• If you have an altered immune system (reduced immunity to infectious diseases), whether congenital, acquired, caused by medications or other treatments.
• If you are HIV positive.
• If you are pregnant or breastfeeding.
• If you have a fever and its origin is unknown.
• If you have undergone any medical or surgical procedure in the bladder in the preceding week, due to the risk of a systemic infection by the BCG bacteria.

Warnings and precautions

Consult your doctor or pharmacist before starting to use OncoTICE.

• Before the first instillation of OncoTICE in the bladder, your doctor may perform a skin test (tuberculin test) to investigate if you have a tuberculosis infection.
• In case the bladder wall or urethra are damaged or injured during the insertion of the catheter, treatment will have to be postponed until the injury has healed. During the administration of OncoTICE, precautions are taken to avoid introducing contaminants into the urinary tract or causing unnecessary damage to the urinary mucosa.
• It is essential to rule out the presence of the HIV virus. You may need to provide a blood sample for this investigation. Your doctor may also ask if you have any risk factors, such as unprotected sex, use of dirty needles, or if you have received blood transfusions.
• To protect your partner from the transmission of the BCG bacteria, it is recommended not to have sex during the week following OncoTICE treatment. If you use a condom, you can have sex, as long as it is used correctly and does not break.
• You will be monitored after each instillation of OncoTICE to prevent toxicity and systemic infection by the BCG bacteria.
• If an accidental contamination of OncoTICE is suspected, you may be required to undergo a tuberculosis detection test at the time of the accident and 6weeks later.
• If the tuberculin test is performed after treatment, the result may be positive.
• If you experience symptoms such as fever and unexplained weight loss, you should contact your doctor, as these symptoms may indicate a late onset of BCG infection. These symptoms can be delayed from months to years after the last dose of OncoTICE.

Use of OncoTICE with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The following medications or therapies may reduce the effect of OncoTICE:

• Antibiotics, especially antitubercular medications such as streptomycin, para-aminosalicylic acid (PAS), isoniazid, rifampin, and ethambutol.
• Medications that suppress the immune system (immunosuppressants).
• Medications that suppress bone marrow cell production (bone marrow suppressants).
• Radiation therapy.

If you are using any of these medications or treatments, your doctor may delay OncoTICE treatment until you have completed your current treatment.

Be aware that these instructions may also apply to medications that have been taken or used before or may be taken or used afterwards.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

OncoTICE should not be administered during pregnancy.

OncoTICE should not be administered during breastfeeding.

Driving and operating machinery

Very rarely, the ability to drive or operate machinery may be affected. However, please avoid performing tasks that require special attention until you know how you tolerate the medication.

OncoTICE is administered by instillation into the bladder, usually once a week for 6 weeks, followed by a weekly instillation for 3 consecutive weeks in months 3, 6, and 12 after the start of treatment. If necessary, the 3-week treatment regimen can be repeated every 6 months after the first year of treatment, but not for more than 3 years.

To administer OncoTICE, the contents of one vial, previously reconstituted, will be mixed with 50 ml of physiological serum. First, the bladder will be emptied through the same catheter through which the OncoTICE solution will be instilled into the bladder. It is essential that you do not drink any liquids during the 4 hours prior to the start of treatment. The OncoTICE solution should remain in the bladder for 2 hours to achieve the optimal treatment result. In this way, the medication will come into contact with the entire wall of the bladder. For this reason, you will be asked to move at regular intervals. It is very important not to urinate until 2 hours have passed since the start of treatment.

It is essential that, within 6 hours after treatment, you urinate while sitting and that 2 cups of domestic bleach are added to the toilet after each evacuation. The bleach and urine should be left in the toilet for 15 minutes before flushing the water.

If you receive more OncoTICE than you should

The OncoTICE suspension is prepared by medical personnel and it is unlikely that you will be administered an excess of OncoTICE. If this occurs, however, your doctor will carefully check that there are no symptoms of BCG infection. If necessary, you will receive medications against tuberculosis.

In case of accidental exposure, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common side effects (may affect more than1 in 10people):

• bladder inflammation
• pain while urinating, frequent urination, and blood in the urine. These symptoms usually disappear in two days.
• flu-like symptoms, such as fever, fatigue, and general feeling of being unwell. These symptoms can even appear 4 hours after treatment and last for 24 to 48 hours.

Common side effects (may affect up to1 in 10people):

• joint pain
• arthritis
• muscle pain
• nausea and vomiting
• abdominal pain
• diarrhea

• pneumonia inflammation
• anemia
• urinary incontinence
• urinary tract infection
• urinary urgency
• abnormal urine test results
• febrile chills.

Rare side effects (may affect up to1 in 100people):

• skin rash
• hepatitis with jaundice (yellowing of the skin or eyes)
• abnormal liver function test results
• decrease in red blood cells or platelets, possibly associated with symptoms such as fatigue and/or bruises
• decrease in white blood cells
• pus in the urine
• difficulty urinating
• bladder constriction and blockage of urine flow
• BCG infection in the body (tuberculosis infections), with the possibility of late onset. Symptoms can be delayed from months to years after the last dose.

Very rare side effects (may affect up to1 in 1,000people):

• cough
• epididymitis inflammation (a tube found in the testicles).

Very rare side effects (may affect up to1 in 10,000people):

• hair loss
• increased sweating
• dizziness (feeling of spinning)
• headache
• muscle tension increase
• abnormal sensation such as itching, burning, pins and needles, or hives
• conjunctivitis
• loss of appetite
• indigestion and gas
• confusion
• drowsiness
• weight loss
• low blood pressure
• bronchitis
• difficulty breathing
• sore throat
• runny nose
• swelling of lymph nodes
• kidney function insufficiency
• granuloma (nodule in an organ)
• glans inflammation
• testicular inflammation
• Reiter syndrome (inflammation of the eyes, joints, and genitourinary system)
• lupus vulgar (skin tuberculosis)
• prostate inflammation
• prostate-specific antigen (PSA) elevation (prostate analysis)
• burning, itching, and pain in the female genital area
• back pain

• chest pain

• fluid retention in the extremities.

Other side effects observed with unknown frequency (cannot be estimated from available data):

• allergic reactions
• inflammation of blood vessels, including those in the brain (vasculitis)
• abnormal arterial dilation due to bacterial infection (infected aneurysm)
• inflammation of the eye(endophthalmitis infection).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store in refrigerator (between2°Cand8°C). Store in original packaging to protect it from light.

Keep this medication out of sight and reach of children.

OncoTICE is stored in the hospital according to the manufacturer's instructions on the packaging. The expiration date is printed on the same.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD.

Composition of OncoTICE

• The active principle is the bacillus of Calmette-Guerin (BCG). It is a bacteria adapted for OncoTICE. Each vial of glass contains 2-8 x 10^8 colony-forming units (CFU).
• The other components are lactose monohydrate, L-asparagine monohydrate, citric acid monohydrate (E-330), dipotassium hydrogen phosphate, magnesium heptahydrate sulfate, iron ammonium citrate, glycerol (E-422), zinc formate and ammonium hydroxide (E-527).

Appearance of the product and contents of the packaging

OncoTICE is presented in the form of a powder to prepare a liquid for instillation, which once prepared is introduced into the bladder via a catheter.

OncoTICE is available in packs of 1 and 3 vials, each containing approximately 2-8 x 10^8 colony-forming units of Calmette-Guerin bacilli.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Merck Sharp & Dohme de España, S.A.

Josefa Valcárcel, 42

28027 Madrid, Spain

Tel.: 91 3210600

Responsible for manufacturing

N.V. Organon

Kloosterstraat 6

5349 AB Oss, Netherlands

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem, Netherlands

Date of the last review of this leaflet:12/2021.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/